FOREWORD

June 2007 Foreword from Dr A D Damodaran

Greetings and June  2007, Foreword

Dear Sirs/Friend,

Sub: Foreword www.patentmatics.org June 2007.

                1.After three months of ‘vacation period’ due to technical and other unavoidable reasons, patentmatics is again before you continuing its chosen odyssey of defending the interests of IPR and Related S&T and Development issues as applied to our country and to those alike among the developing nations.

                2.As briefly indicated in the previous Issue, the Mashelkar Committee Report has been creating great ripples among many sections including experts concerned with IPRs in our country, leave alone from even one of its members. Major issues raised are:

(a)     “The analysis is thin, spread across a few pages in a report otherwise populated by secondary data and summaries of submissions by outside parties…Many of the conclusions with respect to new chemical entities (and half the exercise of the entire report) have been extracted word by word from a paper published earlier in 2006 (“Limiting the Patentability of Pharmaceutical Inventions and Micro organisms: A Trips Compatibility Review”) by the Intellectual Property Institute (UK) …by its author Shamnad Basheer… a doctoral student and an Associate at the Oxford Intellectual Property Institute, University of Oxford…..financially supported by Interpat, a Swiss association of major European, Japanese and US research-based pharmaceutical companies committed to improvement of IP laws around the world…. So a committee of five renowned experts takes an year and half to deliberate a patent law issue that is crucial to millions of people in India, and finally produces a report whose key conclusions are borrowed, without acknowledgement…” – Chan Park and Achai Prabhala in “First Attempt to dent a compromised patent system”, The Hindu).

(b)     Now that the GOI has granted permission (?) to ‘resubmit’ the plagiarism-hit report, one of its members Prof NR Madhava Menon, while asserting that he stands by the conclusions of the committee report, has publicly opined that the committee should ‘ideally’ take this opportunity to address the charge levelled by the Left parties, public health experts and IPR experts that its recommendations are ‘against national interests’ (Manoj Mitta, Times of India).

(c)     Under the auspices of the well-known National Working Group on Patent Laws, a formal report has been submitted. It concludes (1) The conclusions of the Report are totally biased and without cogent arguments and are not based on the clarifications provided in the Doha DECLARATION ON trips agreement and Public Health which ‘affirms that the Agreement (TRIPS) can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and in particular to promote access of medicines to all’, clarifying enough for exercising our right to determine the scope of patentability for pharmaceutical substances and micro organisms which are crucial to promote access to medicines for all.

There are indications that, though for ‘wrong’ reasons, many members of parliament may opt for reopening the crucial provisions of the amended patent law for a total review in view of the unfolding hard realities challenging the drugs sector.

                It is in this context that many view at the case of the anticancer drug Gleevec under contest by the Swiss-based Novartis and that too for over three years! To briefly recapitulate the story, this drug was originally granted an Exclusive Marketing Right as per the extant law (according to which there was to be no patentability criteria to be even considered within the country as cleverly argued by the Novartis counsel Shri P Chidambaram) and accordingly the Chennai High Court granted exclusive rights to import and market the drug to Novartis and concurrently also denied rights to Indian drug companies to manufacture and sell its generic versions. This decision of the HC resulted in turn in the ‘expected’ rise in the drug cost nearly ten times. After the final amendment of the patent Act in 2005, Novartis was required again to get its patent validated; and the Controller General had refused to grant it! Novartis in turn approached the Chennai HC challenging the above decision. Its attorney even challenged the very Indian law as amounting to violating its WTO/TRIPS Treaty obligations! To quote the argument of Novartis from a respected daily, “Assailing the rejection order dated January 25,2006, as well as the amended provisions of the Act, the petitioner said that the latter was unconstitutional as it was against the Agreement On trips of the WTO, to which India was a signatory. Section 3(d) (based on which the patent was rejected by the Controller), was a conscious breach of India’s obligation under TRIPS and that while amending the Section the legislature completely ignored the rationale underlying in Article 253 and 51(a) of the Constitution which mandates the government or court to mould original law in harmony with international treaties”. Better late than never, the GOI has subsequently appointed the statutory Appellate Board and hopefully the case will be through soon one way or another, even though the affected party can still approach the Supreme Court for a final decision. In summary, even a crucial item like the anticancer drug Gleevec is yet available to the Indian patients, rich or poor, only at the Novartis dictated cost! Is the much-trumpeted amended Indian Patent Act a “people-friendly or MNC-friendly” legislation? What could have been the Indian situation if the earlier government then headed by late Mrs Indira Gandhi had not enacted the celebrated 1970 Act based on the much-acclaimed techno-legal report of late Justice Rajagopal Ayyangar? Years ago when Gleevec was granted EMR, patentmatics had raised the question: Is it a TRIPS-dictated Cure or Beginning of the Health Sector Malignancy? Whether arising from the controversial Mashelkar Committee Report or not, the parliament must take up the issue on top priority and formulate an appropriate Law to serve the interests of those Indians who suffer and NOT the business interests of the pharma giants, whether be foreign or native. Given the political will for the august assembly and the Executive, there are now also many techno-legal experts in India who can make even late Justice Rajagopal Ayyangar feel proud! The Indian scientific-techno-legal community including their acclaimed Academies has much responsibility to come forward and  contribute their might and professional authority to sensitise the nation and its contemporary leadership in this regard, which they must fulfil as is being done by their nuclear fraternity in more than abundant measure.

                2. If that was the manner in which the parliament had gone through the TRIPS-dictated conditionalities and had effected the patent law amendment as it thought fit, the case of the infamous Indo-US Nuclear Agreement is being handled by the government almost unilaterally without agreeing even “to set its terms by the parliament”. This is clear amazingly enough from the very recent statement of the General Secretary of one of its major alliance partners, the Communist Party of India (Marxist), which demanded that the Man Mohan Singh Government state clearly what was being negotiated with the United States under the 123 agreement. He added,” As usual we come to know through the United States that 90 per cent of the agreement is through. Our Government has not told us”. Fortunately enough, many serious analysts including senior experts like Drs MR Srinivasan and PK Iyengar (both former Chairmen/AEC) and many others have by now fully and steadily exposed the irreversible dangers emanating from the Agreement through the Indian press. To summarize essential ones,

(a)     "FOR ALL the controversy that nuclear negotiations between India and the United States have generated since July 2005, there is one point on which the supporters and opponents of the deal in both countries tend to agree wholeheartedly: the nuclear agreement is not about energy." Writes Siddarth Varadarajan of the Hindu on May 2,2007, after giving a state-of-art analysis of the Indo-US Nuclear Agreement! A point raised by patentmatics even as early as 2006 repeatedly.

(b)     The Public Sector industries such as BHEL and NTPC are being encouraged to enter into nuclear energy so that hopefully Atomic Energy Act 1962 need not be amended! But whether its potential foreign technology supplier will allow the ‘non-patentability’ clause for nuclear systems and materials is yet to be seen!

(c)      Even before India is entering the world market, uranium prices have started going up even as high as ten times at $100, perhaps peaking towards even as high as 150 according to expert analysts in the field. In other words, resorting to energy security through import of uranium could be even dimmer.

(d)     The successful launch of Agni III has added another dimension in our quest for national security. In other words, our terms of negotiation will certainly be of a widely different content and scope from hereafter, whether they arise from NPT or CTBT.

(e)     Any one going through the well laid out clauses in the Additional Protocol INFCRC/540 of IAEA (Hyde Act insists that India must fulfill the above) will realize how impossible it is going to be for DAE to implement “fireballs” for its scientists working in the civilian and strategic areas related to say reprocessing of spent fuels. If such ‘fireballs’ need be enforced in the delivery systems also as part of NPT/CTBT obligations (Missiles include even Sounding Rockets!), the task becomes even more impossible, then of course the fall-outs of the Hyde Act could befall the activities of ISRO and DRDO as well!

Last but not the least, it is now unequivocally clear that the interests of US in pushing India through the 2005 Agreement is essentially only to bring in and in turn chain the latter within its strategic embrace as part of a long and systematic diplomatic drive initiated from the seventies itself after the first Peaceful Nuclear Explosion at Pokran and the latest ones in 1998. The veteran US Deputy Secretary of State from 1994 to 2001 Strobe Talbott in “Engaging India, Diplomacy, Democracy and the Bomb” has brilliantly described the games on how far and what happened during the NDA regime. Who knows, another US diplomat may unfold authoritatively the going-on under the UPA Regime; both times everything held away from the Indian parliamentarians!

It is in this connection that one senior “concerned Indian citizen” has now filed a Public Interest Litigation in the Supreme Court challenging the matter thus: (Three reports have been given below to enable the reader a more or less complete picture)

                (a)“PIL seeks nuke deal direction

By Our Special Correspondent  (Asian Age / May 12, 2007)

New Delhi, May 11: A public interest litigation (PIL) has been filed in the Supreme Court seeking a direction to restrain the Union government from signing any agreement on the nuclear deal between India and the US till it is thoroughly examined by a committee appointed by the top court. This newspaper had first reported on May 8 that a PIL will be filed before the Supreme Court seeking judicial intervention to stop the signing of the bilateral agreement on the civilian energy nuclear deal between India and the US until a level of transparency is ensured through a public debate over all aspects of the accord. The petition has been filed by Mumbai-based M.N. Ramamurthy, an IIT metallurgist who is an active member of the Mumbai-based Forum for Integrated National Security that had recently organized a meeting of nuclear scientists on the nuclear deal. In his petition, Mr. Ramamurthy has referred to the statement made by the Prime Minister in Parliament about the bilateral agreement on nuclear issues with the US based on the Hyde Act. The petitioner contended that the consequence of such "acts and omissions" by the executive are "far too serious and grave" for the country and the matter cannot be left to the wisdom of the executive alone.

There was immediate need to examine its implications on national security, sovereignty and dignity of the country, the petitioner stated.

(b)Hearing on nuke PIL tomorrow  

 Seema Mustafa (Asian Age / 17 05 2007)

New Delhi, May 16: The Supreme Court, in a sudden move, has decided to schedule the hearing of the public interest litigation case moved by an Mumbai-based IIT alumnus, Mr. K.M. Ramamurthy, seeking transparency in the negotiations on the Indo-US nuclear deal and full accountability of the government to Parliament, on Friday. The Union government, worried about the initial reports on the PIL that had appeared in this newspaper, had rushed to move a caveat in the court pleading that no decision be taken without giving the respondent (in this case the government) a hearing as well. Mr. Ramamurthy, who has now arrived in New Delhi from Mumbai, is busy preparing the case that he will plead in court himself. “I do not know what the court will do, this is the first time I will be ever going into any court. I am just a good South Indian Brahmin trying to do my work,” he said when contacted. He said he was absolutely taken aback when he was told to appear before the Supreme Court on May 18. The Supreme Court, if it admits the PIL on Friday, could in effect stay the negotiations if it decides to do so and postpone the final hearing to after the summer vacations.

Mr. Ramamurthy has pointed out in his petition that the government should take the public and Parliament into confidence over these crucial negotiations, and get the approval of Parliament before signing any bilateral nuclear agreement with the United States. Seeking judicial intervention, Mr. Ramamurthy, who has been concerned about the manner in   which the nuclear deal is being negotiated with the US, is optimistic of a favorable order that will ensure a degree of transparency and accountability insofar as the nuclear deal is concerned. Prime Minister Man Mohan Singh and US President George W. Bush are both coming under tremendous pressure from powerful lobbies within their own countries not to yield ground while negotiating the 123 agreements, and to remain accountable to Parliament and the US Congress respectively. In Washington, a number of experts have written to the House of Representatives, urging its members to “communicate to the White House that you will oppose any proposed agreement for nuclear cooperation with India that does not explicitly meet the requirements outlined in US law and other well-established US policies for civil nuclear cooperation.” The letter makes it clear that “the US negotiating position is shaped” by the provisions of the Henry Hyde Act and the relevant portions of the Atomic Energy Act, which includes Section 123 on agreements for nuclear cooperation. The letter points out very categorically that “if the administration concludes the negotiation (with India) by conceding to the Indian position in certain areas, the result could be reduced accountability, increased Indian nuclear weapons capacity, further damage to the credibility of US non-proliferation efforts and a proposed agreement for nuclear cooperation that is inconsistent with minimal conditions for trade established by law by Congress.” Pointing in detail to the drawbacks of making any exceptions for India, the letter urges US Congressmen to reject any agreement that falls short of respecting the latter and the spirit of the requirements set forth in US law, in particular the Hyde Act. The US point person for the nuclear deal, undersecretary of state for political affairs Nicholas Burns, will be here next week to “conclude” the negotiations that will then await the political push in the final lap by President Bush and Prime Minister Man Mohan Singh. It is very clear that the two leaders have taken what the US had described as a “political decision” to wrap up the negotiations on the bilateral agreement. Dr Singh did not make a statement on the nuclear deal in this session of Parliament despite demands by several MPs that he makes the government position on the 123 agreement clear. Under Indian law, unlike in the US, the government is not required to secure Parliament’s approval before signing the bilateral agreement. It is in this context that the Supreme Court’s ruling on the PIL urging it to intervene to ensure a greater degree of transparency on the nuclear deal becomes crucial.

      According to Indian Express, “the Government has its fingers crossed with the Supreme Court slated to hear a Public Interest Litigation on the nuclear deal on Friday - the last day before the SC breaks up for vacation. The petition, still to be admitted, seeks direction from the court to restrain the Government from proceeding further with the final signing of the agreement “without adequate public mandate” and bring it before Parliament. It has got the Government worried because anything short of dismissal of the petition could hold up negotiations on the 123 agreement given that the SC will return from vacation only on July 9. Although there is always a Vacation Bench, sources said, this entire process could delay matters at a time when there is urgency to finalize an agreement. While the petitioner in the PIL is M N Ramamurthy, an IIT Mumbai graduate, it turns out that he is part of an unregistered Forum for Integrated National Security (FINS) that has held seminars in Mumbai where P K Iyengar, Homi Sethna and A N Prasad - former heads of the Department of Atomic Energy and its affiliate institutions - have come and spoken against the nuke deal. In case the petition is admitted, it will spell bad news for negotiators who are trying to seal the 123 agreement around the time PM meets US President George Bush on the margins of the G-8 Outreach Summit in Berlin on June 8.Judging the gravity of the situation, hectic consultations are on between MEA and the Solicitor General’s office to make a strong case and get the petition dropped on Friday itself. On the face of it, the petition makes demands that can easily be countered but its timing and its listing on the last day before the SC vacation has South Block worried. The petition asks the apex court to give a direction to the Government to release “draft-by draft” the full text of the proposed agreement under negotiations.

About nine points raising serious questions on the country’s security and sovereignty being put to stake with the signing of the agreement have been raised in the petition filed under Article 32 of the Constitution. But sources said that the Government will tell the court that all these issues have been convincingly dealt by the Prime Minister on several occasions before Parliament.

Continuing the matter, Asian Age reported that The Supreme Court has given till July 9 to petitioner M.N. Ramamurthy to prepare for the hearing of his Public Interest Litigation on the nuclear deal. A two-judge bench, including the Chief Justice of India K.G. Balakrishnan, heard a special mention by Mr. Ramamurthy and as requested by him, agreed to take up the PIL after July 9 when it sits again after its summer vacations.

The PIL is seeking judicial intervention to ensure that the government does not sign the nuclear agreement with the United States "until the same is thoroughly examined by a committee appointed by this Hon’ble Court in respect of its immediate need and essentiality and its implications on national security, sovereignty, dignity and honor and till the matter is thoroughly discussed and passed in the Parliament."

The Chief Justice asked Mr. Ramamurthy, "How much time do you want" to which the petitioner said that he would leave it to the court to decide. The Chief Justice then said that the PIL would be taken up after July 9 as the court is adjourning for its summer vacations on Friday. The Attorney General and the additional attorney general who were, however, not given a chance to speak represented the government that is clearly very worried about the case.

The Chief Justice of India’s decision to accept the PIL as well as the petitioners plea for more time to prepare for the case makes it difficult for Prime Minister Man Mohan Singh to sign the 123 Agreement during the intervening period, as the government will then have to explain before the apex court why a decision was reached before it could consider the PIL seeking greater transparency and accountability insofar as the proposed agreement is concerned. Legal experts pointed out that if it became known that the government was moving to sign the 123 Agreement during the intervening period, a petition could be filed before the vacation court for a stay order now that the PIL had been admitted by the Supreme Court.Mr Ramamurthy said that he could not say what the legal consequence of the Supreme Court decision today was as he was not well versed in the law, but that it should definitely exercise an ethical and moral restraint on the government. The petition has cited details from the Henry Hyde Act and the two statements made by Prime Minister Man Mohan Singh to Parliament on the nuclear deal to maintain that if the former is incorporated in the bilateral agreement between New Delhi and Washington "as it must" it would cause "grave harm and injury to Indian populace and India’s dignity and sovereignty." The petition has spelt in some detail the concerns arising out of the current negotiations that have been listed as:

The US assurance on the supply of uranium fuel is deceptive and illusory;

The US certification on India’s nuclear activities is uncalled for;

India’s nuclear installations shall be perpetually under the US scanner;

The US authorities shall be peeping on all Indian nuclear activities;

The US intends to have the right to discipline India;

The US will scuttle India’s defense strategies;

The US will be interfering with India’s over all nuclear policy;

India’s sovereignty will be compromised and foreign policy be dictated by the US;

Extraneous issues are being linked to nuclear sciences and are being forced upon India.

The petition also refers to the Prime Ministers claim that the "Constitution of India provides the Union executive the unfettered power/authority to enter into any treaty/bilateral/multilateral agreement which can be exercised without taking into confidence the Parliament or people or group of people directed connected or affected thereby." It then points out that the "consequences of such acts and omissions by the executive are far too serious and grave for the country that the matter cannot be left to the wisdom of the executive alone. Indian people and peoples representatives ought to be given an opportunity to deliberate and debate the issues involved."

The petitioner has submitted that the assurance of the Prime Minister that Parliament shall be fully informed "is an eye wash and the people of India cannot remain mute spectators in this manner considering the past experience the Indian public had with the WTO treaties signed by the union executive without consulting or without taking into confidence either the Parliament or public or group of people/institutions to be affected thereby." He has further said that it is a "misconceived notion" that the executive has unfettered powers to sign and execute bilateral agreements/treaties. Apart from the main prayer to set up a committee to examine the agreement, the petitioner has as interim relief urged the Supreme court to direct the respondents to "release draft by draft full texts of the proposed agreement with the US for public information and invite comments thereon and take cognizance thereof as required and deem first and proper in the interests of the country."

©According to The Hindu,” The Supreme Court has been moved to restrain the Union Government from hurriedly executing the Indo-US nuclear deal. A Bench headed by the Chief Justice of India, K.G. Balakrishnan has posted it for hearing in July on the request of the petitioner, M.N. Ramamurthy of Mumbai. The petitioner said pursuant to the Joint Statement of July 18, 2005 by the U.S. President and India's Prime Minister for collaboration in the field of nuclear energy among others, the two countries were required to amend their domestic energy legislation. The U.S. amended its Atomic Energy Act, 1954 and the said amendments were incorporated in the Henry J. Hyde U.S.-India Peaceful Nuclear Energy Act, 2006 that became the law of the land on December 2006.He said: "If India has to comply with the provisions of the Hyde Act 2006 in the proposed bilateral agreement which in fact it must, the following important points emerging from there are of great concern: the U.S. assurance on supply of uranium fuel is deceptive and illusory; the U.S. certification on India's nuclear activities is uncalled for; India's nuclear installations shall be perpetually under the U.S. scanner; the U.S. authorities shall be peeping in India's all nuclear activities; the U.S. intends to have right of discipline India; the U.S. will scuttle India's defense strategies; the U.S. will be interfering with India's over-nuclear policy; India's sovereignty will be compromised and foreign policy be dictated by the U.S. and extraneous issues are being linked to nuclear sciences and are being forced upon India." The petitioner submitted that the "consequences of such acts and omissions by the executive are too far serious and grave for the country that the matter cannot be left to the wisdom of the executive alone. Indian people and people's representatives ought to be given an opportunity to deliberate and debate the issues involved.

Directive sought He sought a direction to the Center to refrain from hurriedly executing the agreement with the U.S. till the same was thoroughly examined by a committee appointed by the apex court, in respect of its immediate need, essentiality and legality and its implications on national security and till the matter was thoroughly discussed and debated in public and passed in the Parliament."

      The case is attracting very wide interest among the constitutional pundits as well. Reportedly, a PIL is already under the review of Delhi HC questioning the unilateral Treaty Making Powers of the Executive without permission of the parliament. In a way, the PIL in the Apex Court also is of a similar nature. Months ago, it needed an Open Letter from six senior nuclear scientists including three (Rtd) Chairmen, AEC to reorient the discussions on the Indo-US Nuclear Agreement in both houses of parliament and make them more meaningful and nation-centric. So also the repeated assertion by Dr Anil Kakodkar, Chairman/AEC that spent nuclear fuel reprocessing is to be non-negotiable and that Hyde Act actually has amounted to “US shifting goal posts”. It is hoped that the PIL will open up the eyes of the parliamentarians to assert their rights in ensuring democratic governance by an otherwise semi-authoritarian Executive. Equally serious is the democratic need to establish formal structures to involve experts and generalist-career bureaucrats in a synergic mode to protect vital national interests through input of adequate technical expertise and NOT to continue to restrict the same within the latter sector alone. The earlier Prime Ministers had invariably realized the value of advice and guidance of eminent scientists like Mahalanobis, Homi Bhabha, Vikram Sarabhai and such stalwarts in such complicated policy matters. Their successors made our nation proud through successful implementation of the founders’ dreams. But the contemporary political successors have of late forgotten those rich traditions. As Dr Iyengar laments in his latest article “Controversy over 5the Nuclear Deal” (The Hindu dated May 31,2007),”Unfortunately, in India scientists no longer have influence on the nuclear policy of the government. Technical realities and long-term programs based on scientific expertise and the collective wisdom of half a century are dismissed with neither thought nor debate. The vision of a self-reliant nuclear India that Jawaharlal Nehru and Homi Bhabha envisioned, and which Indira Gandhi and Rajiv Gandhi nurtured and sustained, seems now ready to be consigned to the dustbin of history… FDI will not turn nuclear power economical, and ‘outsourcing’ nuclear power will not ensure our energy security. It is the creativity of Indian scientists and their work in Indian laboratories alone that can prove beneficial to the future of the country… Decision needs to be taken and urgently for the civilian and strategic nuclear program, but not without thought, consideration, consultation and an appreciation of scientific realities. This is the time not for politics but for statesmanship”.     Three days ago the nation once again got refreshed from the memory of late Jawaharlal Nehru. India’s Nehru was dead on May 27,1964. But his India is for all of us to make.

Last but not the least, in the latest conference of Chief Ministers called by the Prime Minister, "Karnataka Chief Minister H.D. Kumaraswamy, on Tuesday criticized the Centre for seldom consulting State governments on issues relating to World Trade Organization (WTO) and said that even when consultations took place, they were "perfunctory" in nature. Pointing out that various issues that had opened up in international trade under the WTO agreement on agriculture were impinging on domestic agricultural policies and prices also, he said the Centre needed to constitute a permanent secretariat that would interact with the State governments on a regular basis. "State governments need to be fully involved in these issues," he said. For years, patentmatics has been raising this Centre- State issue as an outcome of the WTO Treaty, again another controversial product of the unilateral action of the Executive in the early nineties without approval of the parliament. And it is gratifying at least one State government has now raised this matter in the foremost national body. If the nation had opted for entering the WTO Treaty with adequate study and precautions, as was the case with the G8 countries themselves (!), subsequent things need not have been so deleterious.

Looking forward to your views and suggestions,

Yours sincerely,

A D Damodaran.